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Trial record 40 of 733 for:    warfarin

Apixaban Versus Warfarin in the Evaluation of Progression of Atherosclerotic Calcification and Vulnerable Plaque

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ClinicalTrials.gov Identifier: NCT02090075
Recruitment Status : Completed
First Posted : March 18, 2014
Results First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew J. Budoff, Los Angeles Biomedical Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Atrial Fibrillation
Interventions Drug: apixaban
Drug: warfarin
Enrollment 66
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description

apixaban 5 mg or 2.5 mg po bid

apixaban: 5 po or 2.5 po bid.

warfarin with target INR of 2-3

warfarin

Period Title: Overall Study
Started 33 33
Completed 26 30
Not Completed 7 3
Arm/Group Title Apixaban Warfarin Total
Hide Arm/Group Description

apixaban 5 mg or 2.5 mg po bid

apixaban: 5 po or 2.5 po bid.

warfarin with target INR of 2-3

warfarin

Total of all reporting groups
Overall Number of Baseline Participants 33 33 66
Hide Baseline Analysis Population Description
all patients who were initially enrolled.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
 100.0%
33
 100.0%
66
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 33 participants 66 participants
55  (2.4) 60  (1.9) 57  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
Female
14
  42.4%
10
  30.3%
24
  36.4%
Male
19
  57.6%
23
  69.7%
42
  63.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 33 participants 66 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   9.1%
5
  15.2%
8
  12.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
  30.3%
13
  39.4%
23
  34.8%
White
20
  60.6%
15
  45.5%
35
  53.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 33 participants 33 participants 66 participants
33
 100.0%
33
 100.0%
66
 100.0%
coronary calcium  
Measure Type: Number
Unit of measure:  Participants with coronary calcium
Number Analyzed 33 participants 33 participants 66 participants
33 33 66
1.Primary Outcome
Title Coronary Artery Calcium (CAC) Score
Hide Description amount of calcification measured by Agatston Score. The range of values for the Agatston score is 0-10000. Higher score is worse outcome.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
all with follow up scans
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description:

apixaban 5 mg or 2.5 mg po bid

apixaban: 5 po or 2.5 po bid.

warfarin with target INR of 2-3

warfarin

Overall Number of Participants Analyzed 26 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
66  (129.9) 31  (61.5)
2.Secondary Outcome
Title Coronary Plaque on CT Angiography
Hide Description To evaluate if treatment with apixaban therapy, as compared to warfarin therapy, will modify the progression, regression and stabilization of coronary atherosclerosis. Modifications will include differences in plaque volume, composition and arterial remodeling; as well as new atherosclerosis formation. The scale is based upon volume of plaque in the coronary arteries, with zero being no plaque and a higher number being more plaque. There is no scale or maximum measure, this is a linear measure of atherosclerosis volume in the coronary arteries and more is worse. None is best, any plaque is considered worse, and a higher plaque volume represents more atherosclerosis. An individual of average health will have a score of 50.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
all participants with follow up data
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description:

apixaban 5 mg or 2.5 mg po bid

apixaban: 5 po or 2.5 po bid.

warfarin with target INR of 2-3

warfarin

Overall Number of Participants Analyzed 26 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
47  (52) 54  (120)
Time Frame 1 YEAR
Adverse Event Reporting Description same as clinicaltrials.gov
 
Arm/Group Title Apixaban Warfarin
Hide Arm/Group Description

apixaban 5 mg or 2.5 mg po bid

apixaban: 5 po or 2.5 po bid.

warfarin with target INR of 2-3

warfarin

All-Cause Mortality
Apixaban Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Apixaban Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Apixaban Warfarin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/33 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Matthew Budoff
Organization: Los Angeles Biomedical Research Institute at Harbo
Phone: 3102224107
EMail: mbudoff@labiomed.org
Layout table for additonal information
Responsible Party: Matthew J. Budoff, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT02090075     History of Changes
Other Study ID Numbers: 21183-01
First Submitted: March 16, 2014
First Posted: March 18, 2014
Results First Submitted: August 6, 2018
Results First Posted: April 23, 2019
Last Update Posted: April 23, 2019